EMGO Institute, VU University Medical Centre, Amsterdam, The Netherlands.
Podiatry department, Fontys University for Applied Sciences, Eindhoven, The Netherlands.
J Foot Ankle Res. 2011 Mar 31;4(1):11. doi: 10.1186/1757-1146-4-11.
Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Forefoot problems increase with age and are more common in women than in men. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these problems are localised in the forefoot. Little is known about the best way to treat forefoot problems in older people. The aim of this study is to compare the effects of two common modes of treatment in the Netherlands: shoe advice and podiatric treatment. This paper describes the design of this study.
The study is designed as a pragmatic randomised clinical trial (RCT) with 2 parallel intervention groups. People aged 50 years and over who have visited their general practitioner (GP) with non traumatic pain in the forefoot in the preceding year and those who will visit their GP during the recruitment period with a similar complaint will be recruited for this study. Participants must be able to walk unaided for 7 metres and be able to fill in questionnaires. Exclusion criteria are: rheumatoid arthritis, neuropathy of the foot or pain caused by skin problems (e.g. warts, eczema). Inclusion and exclusion criteria will be assessed by a screening questionnaire and baseline assessment. Those consenting to participation will be randomly assigned to either a group receiving a standardised shoe advice leaflet (n = 100) or a group receiving podiatric treatment (n = 100). Primary outcomes will be the severity of forefoot pain (0-10 on a numerical rating scale) and foot function (Foot Function 5-pts Index and Manchester Foot Pain and Disability Index). Treatment adherence, social participation and quality of life will be the secondary outcomes. All outcomes will be obtained through self-administered questionnaires at the start of the study and after 3, 6, 9 and 12 months. Data will be analysed according to the "intention-to-treat" principle using multilevel level analysis.
Strength of this study is the comparison between two common primary care treatments for forefoot problems, ensuring a high external validity of this trial.
Netherlands Trial Register (NTR): NTR2212.
足部问题，尤其是前足问题，会导致活动能力下降和更高的跌倒风险。前足问题随着年龄的增长而增加，女性比男性更为常见。大约 20%的 65 岁以上的人患有非创伤性足部问题，其中 60%的问题位于前足。对于老年人前足问题的最佳治疗方法知之甚少。本研究的目的是比较荷兰两种常见治疗方法的效果：鞋子建议和足病治疗。本文介绍了这项研究的设计。
该研究设计为一项具有 2 个平行干预组的实用随机临床试验（RCT）。在过去一年中因非创伤性前足疼痛就诊于全科医生（GP）的年龄在 50 岁及以上的人，以及在招募期间将因类似症状就诊于 GP 的人，将被招募参加本研究。参与者必须能够独立行走 7 米并能够填写问卷。排除标准为：类风湿关节炎、足部神经病变或由皮肤问题引起的疼痛（例如，疣、湿疹）。纳入和排除标准将通过筛选问卷和基线评估进行评估。同意参加的人将被随机分配到接受标准化鞋子建议传单的组（n = 100）或接受足病治疗的组（n = 100）。主要结局将是前足疼痛严重程度（0-10 数字评分量表）和足部功能（足部功能 5 分指数和曼彻斯特足部疼痛和残疾指数）。治疗依从性、社会参与度和生活质量将是次要结局。所有结局将在研究开始时和 3、6、9 和 12 个月后通过自我管理问卷获得。根据“意向治疗”原则，使用多级水平分析进行数据分析。
本研究的优势在于比较了两种常见的前足问题初级保健治疗方法，确保了该试验具有较高的外部有效性。
荷兰试验注册处（NTR）：NTR2212。
